EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

Orexigen® Therapeutics Reports Third Quarter 2010 Financial Results

San Diego, CA, November 3, 2010 – Orexigen® Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of obesity, today announced financial results for the third quarter of 2010. For the quarter ended September 30, 2010, Orexigen reported a net loss of $14.6 million, or $0.31 per share attributable to common stockholders, as compared to a net loss of $14.4 million, or $0.33 per share attributable to common stockholders, for the third quarter of 2009. As of September 30, 2010, Orexigen had $8.4 million in cash and cash equivalents and an additional $92.2 million in marketable securities, for a total of $100.6 million.

“We had previously set three major goals for the Contrave® program: partnership, approval and launch,” said Michael Narachi, President and CEO of Orexigen. “In the third quarter, we succeeded in executing a North American partnership agreement with Takeda Pharmaceutical Company Limited which we believe will further our goal of a strong, focused, U.S. market entry for Contrave, if approved. With a partnership in place our attention continues to be on the regulatory review process for Contrave.”

Total operating expenses for the third quarter of 2010 were $14.8 million compared to $14.2 million for third quarter of 2009. The increase in operating expenses primarily reflects an increase in license fees, stock-based compensation expense and salaries and personnel related costs, offset partly by a reduction in research and development expenses related to the completion of Contrave Phase 3 clinical trials and completion of the Phase 2 clinical trial for Empatic™. Notably, operating expenses in the third quarter included $3.0 million in milestones paid to third parties related to the execution of the Takeda collaboration.

Conference Call Today at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time)

The Orexigen management team will host a teleconference and webcast to discuss the third quarter 2010 financial results and recent business highlights. The live call may be accessed by phone by calling (800) 884-5695 (domestic) or (617) 786-2960 (international), participant code 70229939. The webcast can be accessed live on the investor relations section of the Orexigen web site at http://www.orexigen.com, and will be archived for 14 days following the call.

About Orexigen Therapeutics

Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of obesity. The Company has filed an NDA with the FDA for its lead investigational product, Contrave®. The U.S. Food and Drug Administration (FDA) has scheduled the Endocrinologic and Metabolic Drugs Advisory Committee meeting on December 7, 2010 and the Prescription Drug User Fee Act (PDUFA) action date has been set for January 31, 2011. The Company’s second product, Empatic™, has completed Phase 2 clinical development. Each product candidate is designed to act on a specific group of neurons in the central nervous system with the goal of achieving appetite suppression and sustained weight loss, through combination therapeutic approaches. Further information about the Company can be found at www.orexigen.com.

Forward-Looking Statements

Orexigen cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “indicates,” “will,” “intends,” “potential,” “suggests,”


“assuming,” “designed” and similar expressions are intended to identify forward-looking statements. These statements are based on the Company’s current beliefs and expectations. These forward-looking statements include statements regarding the anticipated action date for the FDA to complete its review of the Contrave NDA and the potential for, and timing of, approval for Contrave. The inclusion of forward-looking statements should not be regarded as a representation by Orexigen that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risk and uncertainties inherent in the Orexigen business, including, without limitation: risks inherent in the uncertainty of the FDA approval process and other regulatory requirements; the therapeutic and commercial value of Contrave; reliance on third parties to assist with the development of Contrave and the regulatory submissions related thereto; the potential for adverse safety findings relating to Contrave; and other risks described in the Company’s filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Orexigen undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. Further information regarding these and other risks is included under the heading “Risk Factors” in Orexigen’s Quarterly Report on Form 10-Q, which we intend to file with the Securities Exchange Commission this week and will be available from the SEC’s website (www.sec.gov) and on our website (www.orexigen.com) under the heading “Investor Relations.” All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

 

Orexigen    Media       Media      
Graham Cooper    Liz Frank    or    Carolyn Wang      
Chief Financial Officer    WCG       WCG      
(858) 875-8600    (212) 301-7216       (415) 225-5050      


 

Orexigen Therapeutics, Inc.

(a development stage company)

Statements of Operations

(In thousands, except per share amounts)

(Unaudited)

 

     Three Months Ended
September 30,
    Nine Months Ended
September 30,
    Period from
September 12, 2002
(Inception) to
 
     2010     2009     2010     2009     September 30, 2010  

Revenues:

          

Collaborative agreement

   $ 286      $ —        $ 286      $ —        $ 460   

License revenue

     22        22        66        66        507   
                                        

Total revenues

     308        22        352        66        967   

Operating expenses:

          

Research and development

     8,186        9,592        21,753        38,579        238,312   

General and administrative

     6,624        4,592        18,827        12,254        74,826   
                                        

Total operating expenses

     14,810        14,184        40,580        50,833        313,138   
                                        

Loss from operations

     (14,502     (14,162     (40,228     (50,767     (312,171

Other income (expense):

          

Interest income

     21        47        101        295        9,113   

Interest expense

     (165     (318     (501     (1,070     (4,307
                                        

Total other income (expense)

     (144     (271     (400     (775     4,806   
                                        

Net loss

     (14,646     (14,433     (40,628     (51,542     (307,365

Accretion to redemption value of redeemable convertible preferred stock

     —          —          —          —          (78

Deemed dividend of beneficial conversion for Series C preferred stock

     —          —          —          —          (13,860
                                        

Net loss attributable to common stockholders

   $ (14,646   $ (14,433   $ (40,628   $ (51,542   $ (321,303
                                        

Net loss per share attributable to common stockholders - basic and diluted

   $ (0.31   $ (0.33   $ (0.86   $ (1.38  
                                  

Shares used in computing net loss per share attributable to common stockholders – basic and diluted

     47,440        43,087        47,295        37,484     
                                  


 

Orexigen Therapeutics, Inc.

(a development stage company)

Balance Sheets

(In thousands, except share and par value amounts)

 

     September 30,
2010
    December 31,
2009
 
     (Unaudited)        

Assets

    

Current assets:

    

Cash and cash equivalents

   $ 8,372      $ 37,658   

Investment securities, available-for-sale

     92,233        54,500   

Prepaid expenses and other current assets

     1,850        1,529   
                

Total current assets

     102,455        93,687   

Property and equipment, net

     990        1,324   

Restricted cash

     881        1,290   

Other assets

     299        547   
                

Total assets

   $ 104,625      $ 96,848   
                
Liabilities and stockholders’ equity     

Current liabilities:

    

Accounts payable and accrued expenses

   $ 6,885      $ 9,828   

Deferred revenue, current portion

     3,517        88   

Long-term debt, current portion

     3,741        6,384   
                

Total current liabilities

     14,143        16,300   

Deferred revenue, less current portion

     47,190        971   

Long-term debt, less current portion

     —          2,416   

Other long-term liabilities

     490        1,258   

Commitments and contingencies

    

Stockholders’ equity:

    

Preferred stock, $.001 par value, 10,000,000 shares authorized at September 30, 2010 and December 31, 2009; no shares issued and outstanding at September 30, 2010 and December 31, 2009

     —          —     

Common stock, $.001 par value, 100,000,000 shares authorized at September 30, 2010 and December 31, 2009; 47,556,739 and 47,215,479 shares issued and outstanding at September 30, 2010 and December 31, 2009, respectively

     48        47   

Additional paid-in capital

     350,115        342,599   

Accumulated other comprehensive income (loss)

     4        (6

Deficit accumulated during the development stage

     (307,365     (266,737
                

Total stockholders’ equity

     42,802        75,903   
                

Total liabilities and stockholders’ equity

   $ 104,625      $ 96,848